Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, ...
FDA Device Recall #Z-1181-2018 — Class II — December 1, 2017
Recall Summary
| Recall Number | Z-1181-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 1, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ohmeda Medical |
| Location | Laurel, MD |
| Product Type | Devices |
| Quantity | 1,179 (1,004 US; 175 OUS) |
Product Description
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
Reason for Recall
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Distribution Pattern
USA (nationwide)
Lot / Code Information
Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
Other Recalls from Ohmeda Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0041-2020 | Class II | Giraffe Omnibed - Product Usage: The OmniBed is... | Oct 5, 2018 |
| Z-1503-2017 | Class II | Giraffe Spot PT Ohmeda Medical Spot PT Lite Ph... | Nov 18, 2016 |
| Z-1504-2017 | Class II | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed... | Nov 18, 2016 |
| Z-1502-2017 | Class II | Giraffe Incubator The Giraffe Incubator is an ... | Nov 18, 2016 |
| Z-1511-2017 | Class II | IWS Infant Warmer System-Infant radiant warmer... | Nov 18, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.